Bio-Reign BioActive BR-025

GUDID 00813954026015

Extra Moldable Bone Graft Matrix

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954026015
• NIH Device Record Key: be5305f1-fa85-4438-af3e-a580f92f209b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Reign BioActive
• Version Model Number: BR-025
• Catalog Number: BR-025
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com
• Phone: 201-488-1549
• Email: support@royalbiologics.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954026015 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-12
• Device Publish Date: 2023-10-04

Devices Manufactured by COLLAGEN MATRIX, INC.

• 00813954026497 - CollaShield Extend: 2024-12-05 Long Term Collagen Membrane
• 00813954026503 - CollaShield Extend: 2024-12-05 Long Term Collagen Membrane
• 00813954026510 - CollaShield Extend: 2024-12-05 Long Term Collagen Membrane
• 00813954026022 - RejuvaKnee: 2024-11-12 Collagen Meniscus Implant
• 00813954026039 - RejuvaKnee: 2024-11-12 Collagen Meniscus Implant
• 00813954026398 - Stylos BA | Putty: 2024-11-08 Bioactive Glass Matrix
• 00813954026404 - Stylos BA | Putty: 2024-11-08 Bioactive Glass Matrix
• 00813954026411 - Stylos BA | Putty: 2024-11-08 Bioactive Glass Matrix